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Completed

NCT Number: NCT01839929

A Study to Assess the Safety and Efficacy of ADVAGRAF (Tacrolimus Modified Release Formulation) in Kidney Transplant Patients Who Were Treated With PROGRAF

The purpose of this study is to evaluate the efficacy of tacrolimus modified release formulation Advagraf® after conversion from Prograf® in stable kidney transplant patients.

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Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Busan, South Korea

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients received a kidney transplant at least 12 months ago prior to enrollment.
  • Patients have taken unchanged dosage of Prograf® and remained stable serum level of tacrolimus at least for 12 weeks prior to enrollment.
  • Patients have kept in unchanged immunosuppressive therapy (combination therapy) at least for 12 weeks prior to enrollment.
  • Female patients of childbearing potential must have a negative urine or serum pregnancy test prior to enrollment, and agreed to the deliberate prevention of conception during the trial.
  • Patients are considered clinically stable by observer's judgment.
  • Patients must understand the purpose and risk of participating the trial and signed on the written consent.

Exclusion criteria

  • Patients have previously received an organ transplant other than a kidney.
  • Patients have had acute transplant rejection within 12 weeks, or acute transplant rejection requiring antilymphocyte therapy within 24 weeks prior to enrollment.
  • Patients newly diagnosed malignant tumors after organ transplant but the patients treated completely with basal or squamous cell carcinoma of the skin are excepted.
  • Patients have a known hypersensitivity to Prograf® or tacrolimus.
  • Patients whose medical condition are able to interfere with the study objectives.
  • Patients who are at the risk of drug abuse or mental disorders or communicate difficulties with the observer.
  • Patients have been participated in another clinical trial, or treated with drugs of clinical trial within 28 days prior to enrollment.
  • Patients have been taken prohibited combination agents within 28 days prior to enrollment.
  • Patients are pregnant or lactating.
  • Patient are HIV-positive.
  • Patients are not able to keep the scheduled visit.
  • Patients whose GFR (MDRD) is in the level of <30 mL/min.
  • Patients who are at the condition of 'Creeping creatinine (defined by 20% increase within 6 months prior to enrollment)
  • Patients whose SGPT/AST and/or SGOT/ALT levels have been elevated greater than 2 times the upper value of the normal range.
  • Patients have FSGS or MPGN Type II as underlying diseases.
  • Patients are with cirrhosis

Treatment and study plan

Prograf

Drug

oral

Other names: FK506, tacrolimus

Advagraf

Drug

oral

Other names: FK506E, tacrolimus modified release formulation

Primary outcomes

  1. Change in glomerular filtration rate (GFR) at Week 24 from baseline

    Time frame: Baseline and Week-24

Secondary outcomes

  1. Change in Blood Pressure (BP) at Week 24 from baseline

    Time frame: Baseline and Week-24

  2. Change in HbA1c at Week 24 from baseline

    Time frame: Baseline and Week-24

  3. Change in tacrolimus blood trough level at Week 24 from baseline

    Time frame: Baseline and Week-24

  4. Safety assessed by the incidence of adverse events, physical exam., vital signs and labo tests

    Time frame: For 24 weeks

  5. Overall frequency of acute rejection

    Time frame: For 24 weeks

Sponsors and collaborators

Lead sponsor

Astellas Pharma Korea, Inc.

Industry

Registry information

Official study title

A Multicenter, Open-label, Single-arm, Non-inferiority Study to Assess the Safety and Efficacy of a Tacrolimus Modified Release, ADVAGRAF® in Stable Kidney Transplant Patients Converted From a PROGRAF® Based Immunosuppressive Regimen

Acronym: PeACE

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Apr 25, 2013
Registry last updated
May 1, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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